A Phase Ib Study of Safety and Pharmacokinetics of Ramucirumab in Combination With Paclitaxel in Patients With Advanced Gastric Adenocarcinomas

作者：Ueda Shinya; Satoh Taroh^*; Gotoh Masahiro; Gao Ling; Do Toshihiko

来源：Oncologist, 2015, 20(5): 493-494.

DOI：10.1634/theoncologist.2014-0440

Background. This phase Ib study evaluated the tolerability and pharmacokinetics of ramucirumab, an anti-VEGFR-2 antibody, combined with paclitaxel as second-line therapy in Japanese patients with metastatic gastric or gastroesophageal junction adenocarcinoma after first-line therapy with fluoropyrimidines and/or platinum.
Methods. Patients received ramucirumab 8 mg/kg on days 1 and 15 and paclitaxel 80 mg/m(2) on days 1, 8, and 15 of a 28-day cycle. Safety analyses included all patients (n = 6).
Results. No dose-limiting toxicities occurred in the first cycle. All patients experienced >= 1 treatment-emergent adverse event (TEAE); 5 patients experienced grade >= 3 TEAEs. There were two deaths caused by disease progression. The best overall responses were stable disease (n = 5) and partial response (n = 1). Patients received ramucirumab and paclitaxel for a median of 12.5 weeks (range: 11.4-42.7 weeks) and 12.2 weeks (range: 11.0-41.0 weeks), respectively. Following a single dose of ramucirumab IV infusion 8 mg/kg, clearance was similar to 0.017 L/hour, half-life (t(1/2)) was 138 to 225 hours, and steady-state volume of distribution (V-ss) was similar to 3 L.
Conclusion. The ramucirumab/paclitaxel combination appears to be well-tolerated in Japanese patients with advanced gastric adenocarcinomas. These results are in line with previous ramucirumab pharmacokinetic studies as anticipated.

• 出版日期2015-5